MAUDE Adverse Event Report: SYNTHES USA SOCKET WRENCH-11MM WIDTH ACROSS FLATS

Catalog Number 321.15

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A service history review was attempted for the subject device but could not be performed because the lot number cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.A service and repair evaluation was also performed for the subject device.The customer reported the universal joint was broken, the socket was no longer attached, and the washer disk may have been missing.The repair technician reported ¿worn-out parts¿ as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the synthes complaint handling unit for additional evaluation.The evaluation was confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the socket wrench-11mm width across flats is broken.Further details indicate that the socket is not attached anymore.A washer disk might be missing from the device as well.The issue was found intra-operatively during an external fixator removal procedure.An eight (8) minute delay in surgery was noted.No additional medical intervention was required to complete the procedure and no patient harm was assessed.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturing review/investigation, but has yet to be received.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the service history records has been requested and is pending completion.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation review was performed.The investigation of the complaint articles has shown that:the part was received with signs of damage possibly caused by excessive torsional forces.One of the tabs meant to work with the dowel pins to help secure the socket to the shaft/handle was bent outward.The true root cause of the complaint condition cannot be determined, but it is most likely that the tool was used outside of its intended use and was subsequently exposed to excessive torsional forces and angularity between the driving shaft and the driven shaft which contributed to the damage which dislodged one dowel pin and ultimately caused the socket to detach from the device shaft/handle.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOCKET WRENCH-11MM WIDTH ACROSS FLATS
• Type of Device: WRENCH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4756815
• MDR Text Key: 13412897
• Report Number: 2520274-2015-13672
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321.15
• Device Lot Number: 8732974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2015; 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1